Status:
COMPLETED
A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Prostate Adenocarcinoma
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is the irradiation of...
Detailed Description
Primary objective phase I: To irradiate the prostate gland which might albeit contain microscopic disease with tumoricidal doses of SBRT, and to escalate the dose of SBRT in the visible prostatic tum...
Eligibility Criteria
Inclusion
- All patients must be willing and capable to provide informed consent
- Histologic confirmation of prostate adenocarcinoma
- T2-T3 tumors, N0 (clinically by no evidence of metastatic lymph nodes on CT or MRI)
- No direct evidence of regional or distant metastases
- PSA less than or equal to 50 μg/ml
- Visible gross tumor at the prostate endorectal coil MRI.
- The ultrasound or MRI based volume estimation of the patient's prostate gland no greater than 70g or 70cc
- No significant urinary obstructive symptoms; IPSS score must be ≤ 15 (alpha blockers allowed)
- Patient must have undergone an endorectal coil magnetic resonance image (MRI) of the prostatic gland (before rectal spacer if any),
- Patient must have undergone the following assessments in case of PSA ≥ 20μg/L, and/or T3 tumor and/or Gleason Score ≥ 8:
- bone scan
- Chest abdominal and pelvis computed tomography (CT) scan
- If tumor is localized at less than 3 mm from the rectum a rectal spacer is mandatory. Patient accepts the rectal spacer to be injected before treatment starts
- Patient accepts to have one planning MRI after the injection of rectal spacer (without endorectal coil)
- Patient accepts the preparation of the bladder (bladder full), before the planning MRI, planning CT and then before each treatment fraction
Exclusion
- Previous radiotherapy in the pelvis
- Tumor localized at less than 3 mm from the urethra
- History of inflammatory colitis (including Crohn's disease and ulcerative colitis)
- Prior cancer in the pelvis
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before inclusion in the trial
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02254746
Start Date
August 1 2014
End Date
November 8 2023
Last Update
February 14 2025
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011